There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Swallowing is a complex process, involving a very fine synchronization of the pharyngo-larynx, with respiration, under the control of the central nervous system and numerous peripheral effectors. Any dysfunction can lead to aspiration a source of morbidity and mortality. These dysfunctions of the aerodigestive tract affect a considerable number of patients with multiple etiologies: squamous cell carcinoma of the upper aerodigestive tract, peripheral or central neurological dysfunctions, neurosurgical or neurovascular causes, geriatric pathologies and intensive care complications. Aspiration pneumopathy is the most severe complication, which can lead to death. For decades, only techniques such as tracheotomy or enteral feeding (nasogastric tube/gastrostomy tube), associated or not with speech therapy, have been proposed to counter this problem. These invasive treatments remain symptomatic. These treatments bypass the pharyngolaryngeal dysfunction without resolving it and still significantly alter the patients' quality of life. In 2012, a first worldwide clinical study (published in the NEJM) based on 6 patients, conducted by the ENT team in Strasbourg, demonstrated an improvement in the quality of life of patients who had undergone total laryngectomy, by proposing the placement of a titanium laryngeal implant equipped with an upper valve. This strategy intended to avoid aspiration of food hile allowing normal breathing. Although this technique did not solve all problems (the persistence of food going the wrong way), this study allowed a conceptual change in the attempt to solve swallowing problems by the introduction of pharyngolaryngeal implants. The latter remains a challenge, but clinical trials of implants with a functional valve effected after removal of the larynx or on an existing but dysfunctional larynx have demonstrated the indivisibility of the pharynx-larynx couple in the search for permanent solutions. This physiological process can be studied with imaging. Videofluoroscopy is the reference method allowing a dynamic study of swallowing. However, it does not allow the study of soft tissue movement and exposes the patient to repeated irradiation. Recently, MRI has shown its ability to visualize the entire pharyngolaryngeal structures accurately and dynamically during the swallowing process. To improve the understanding and resolution of swallowing disorders, a unique robotic platform, consisting of a dynamic silicone skeleton reproducing the complexity of the pharyngolarynx, was initially developed by PROTIP MEDICAL (SWALL-E). This is the object of a French patent, transferred to the HUS University Hospitals of Strasbourg. The aim this study is to correlate and calibrate this platform with dynamic MRI data in healthy subjects, by studying the movement of the different anatomical structures of the pharyngolarynx during swallowing movements (speed, amplitude and synchronization of the pharyngolarynx movements). The immediate application of SWALL-E, after calibration and validation, will: i) allow the reproduction of a physiological swallowing mechanism; ii) allow to produce a pathological and personalized simulation of swallowing disorders in vitro; iii) allow the design of implants produced by 3D printing, and to analyze their effectiveness before implantation; iv) to modify in parallel and if necessary the rheology of the food boluses, thus contributing to a significant global improvement for the patient. Thus, this platform, unique in its conception, aims not only at making a diagnosis of the specific pathology of the patient, but also aims at a personalized management adapted to the patient, inexistent until now. Indeed, if the diagnostic methods are numerous (nasofibroscopy, swallowing transit, videofluoroscopy, study of swallowing noises by acoustic signals, swallowing cinetigraphy...), the treatments have remained identical for decades (speech therapy), and are not targeted (pharyngeal stimulation), despite the fact that each patient presents a specific pathology that is difficult to reunify under a "universal" treatment.
Hemorrhoidal disease is a frequent and disabling condition that is treated medically and surgically. Tri-pedicular hemorrhoidectomy is the most commonly used surgical technique in France. Due to the restrictive postoperative course (pain, secondary risk of bleeding, asthenia, local care several times a day, transit disorders, urinary disorders, nausea/vomiting), conventional hospitalization was preferred to outpatient surgery until 2015 in our department. The motivation to practice ambulatory surgery is in order to satisfy the patients on the one hand and to improve the economic cost of the management on the other hand. According to the HAS, this is a national priority in order to optimize the supply of care. However, situations such as the absence of an accompanying person, the presence of significant co-morbidities or the use of treatment modifying haemostasis do not allow such surgery to be performed on an outpatient basis. Thanks to the implementation of a dedicated care pathway, outpatient tri-pedicular hemorrhoidectomy at the Paris Saint-Joseph Hospital Group has increased from less than 5% in 2015 to more than 80% in 2021. Outpatient care remains a key criterion for the patient in the context of surgical management. The objective of this work is to evaluate patient satisfaction with this type of care pathway and to identify the factors associated with dissatisfaction with outpatient care. The secondary objectives are to determine the associated factors of non-satisfaction, the profile of patients for whom outpatient care would not be desirable, to determine the actions to be taken to ensure that outpatient care is provided in the best possible way, to homogenize outpatient care within the department (oral information and written support before the operation, anticipation of postoperative measures (prescriptions and postoperative appointments given during the pre-operative consultation), postoperative liaison file given to the patient on discharge).
Ambulatory surgery is defined as "surgical procedures scheduled and performed under technical conditions that imperatively require the safety of an operating room, under an anesthesia of variable mode and followed by a postoperative monitoring allowing, without increased risk, the discharge of the patient on the same day of his intervention. It therefore does not include hospital accommodation and represents an alternative to traditional hospitalization. Ambulatory surgery is of interest in a growing number of situations. Its interest lies on the one hand in the obvious economic interest and in the fact that this model corresponds to the expectations of patients in 2021, allowing them to return to their usual living environment as soon as possible. It also reduces the risk of infections associated with care, due to the short duration of the stay and the minimally invasive surgical techniques, without compromising safety conditions. It therefore requires a well-designed circuit, ensuring the quality and safety of care at all stages, to allow an early return home without risk. Since 2011, the French National Authority for Health has defined outpatient surgery as a priority objective in France, setting a target of 70% of surgeries performed as outpatient procedures by 2022. Currently, less than 50% of surgery in France is performed on an outpatient basis, compared to 65% in Belgium, in Northern European countries and even 85% in the United States. As early as 2001, the Assurance Maladie identified gynecological surgery as a surgery with a high potential for development in ambulatory care, particularly breast surgery and gynecological laparoscopy. Many gynecological surgeries benefit from this type of management, in particular because of the low level of patient comorbidity, but the risks of failure are difficult to predict because of the small amount of data available in the literature, particularly in gynecology. Paris Saint-Joseph Hospital inaugurated the Ambulatory Surgery Unit (ASU) in 2018, with a well-defined patient pathway, and outpatient surgical activity in gynecology represents 15% of activity among the 9 surgical disciplines. The aim of this study is therefore to evaluate the safety of ambulatory management of patients operated on at the GHPSJ in the ambulatory surgery unit, in the context of breast surgery or gynaecological surgery, by assessing complications and their risk factors.
The present study evaluate the impact of a communication tool "PICT'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking. The app consists of simple pictograms allowing simple communication between patients and the reanimation care team. The study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.
COVID-19 disease, caused by SARS-CoV-2 first appeared in China, and then spread worldwide. In December 2019, a group of patients with pneumonia of unknown origin were infected after exposure to the market in Wuhan, Hubei Province, China. Very quickly, a new coronavirus was isolated from a sample of a patient's lower respiratory tract and the complete genome of the virus was sequenced. This new coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) for its genetic homology with SARS-CoV, showed a global extension. Thus, on January 30, 2020, the World Health Organization (WHO) announced the outbreak of COVID-19 as an international public health threat, and then in March 2020, the global situation escalated to a pandemic. Johns Hopkins University reported over 7,600,000 cases of infection and over 427,000 deaths as of June 13, 2020. Due to the rapid progression of the COVID-19 pandemic and the limited molecular testing capabilities at the laboratory level, the concept of molecular testing for off-site biology examination appears relevant. Indeed, the urgent need for increased testing for COVID-19 has been clearly identified as an essential element of the strategy to combat the coronavirus worldwide. Indeed, COVID-19 represents a major public health problem currently causing rapidly increasing numbers of infections and significant morbidity and mortality worldwide. As of September 3, 2021, more than 200 million people worldwide have been infected with SARS-CoV-2 and more than 4.5 million have died according to data collected by Johns Hopkins University. Early detection with a sensitive COVID-19 technique is essential to ensure rapid and appropriate patient management, contain the epidemic, and better understand the global epidemiology of the virus. To date, laboratory diagnostics have relied primarily on amplification and detection of viral gene sequences in upper respiratory tract specimens performed in a centralized laboratory. A new test (ID NOW COVID-19) is based on isothermal amplification at 56°C of the gene encoding the RdRp RNA polymerase. This molecular biology test can be performed as an off-site medical examination (EBMD), providing a result in less than 13 minutes directly in the clinical department. This rapidity could allow a more rapid management, isolation and "filiarization" of COVID-19 patients. To our knowledge, there is no study available in the literature evaluating the impact of a rapid examination in delocalized biology on the organization of the management of pregnant women in the delivery room. The objective of this work is to evaluate the organizational impact of parturients who have received a rapid test for SARS-CoV-2. The primary objective is to evaluate the impact of the use of the ID NOW COVID-19 test on the length of stay of parturients in the delivery room. The secondary objectives are to evaluate the time to result, time to isolation and user satisfaction.
The Covid-19 crisis is undoubtedly the most significant event of the early 21st century. The pandemic has profoundly changed our way of life, whether as human beings, but also as patients or caregivers. This pandemic of an incredible magnitude, after having been minimized, blew a wind of fear on the whole world because of the unknown that the SARS-CoV2 virus represented. The world scientific community being destabilized, a great majority of states decided to apply a containment. In France, a strict containment was applied between March 17, 2020 and May 11, 2020 (1 month and 23 days, about 8 weeks). Diabetic and obese patients were designated as "at risk" for infection by COVID 19. Type 2 diabetes is one of the most common chronic diseases in general practice. Its regular management, we know, is largely related to lifestyle, which is particularly important in controlling the disease and preventing complications. During the first months of the pandemic, we witnessed many emergency room visits of patients with chronic pathologies, in full decompensation, due to a lack of follow-up but also due to a lack of treatment. After the first containment, in the endocrinology department of the Paris Saint-Joseph hospital, we observed that many patients had a clear imbalance of their diabetes compared to their previous history. The main objective of this study is to show that the COVID-19 pandemic, and more precisely the strict confinement applied in France from March 17, 2020 to May 11, 2020, had an impact on diabetes control in the study population. The secondary objectives are to study the explanatory covariates via the modification of the lifestyle of diabetic patients (decrease in physical activity, increase in poor dietary habits, psychological impact related to the situation, difficulties in accessing care, modification of work arrangements).
This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group). The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction. The hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction. Group 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction. Group 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture). Subjects will be followed-up to 7 days.
To assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.
This is a research study aiming to identify imaging biomarkers in patients diagnosed with spastic paraplegia type 5 (SPG5)
There are few published data on the benefit of Enhanced recovery program in radical prostatectomy in the management of localized prostate cancer. All the studies available on the subject are retrospective (1-3). This randomized comparative study is proposed in order to compare in a homogeneous population (place and time) the interest of RAAC specifically in this surgery.